Effect of Cryotherapy on Postoperative Pain

Not Applicable

• Conditions: Symptomatic Irreversible Pulpitis
• Interventions: Procedure: normal saline; Procedure: cryotherapy

• Registration Number: NCT03716635
• Lead Sponsor: Cairo University

Brief Summary

the aim of the study is to evaluate the effect of cryotherapy on postoperative pain in molar teeth with irreversible pulpitis and apical periodontitis

Detailed Description

the purpose of the study was to evaluate the effect of 2.5c cold saline irrigation as a final irrigant on postoperative pain after single visit root canal treatment of teeth with vital pulp and apical periodontitis .thirty patients will be included in the study .the teeth will be divided into 2 groups (i.e the control group and the cryotherapy group ) in the cryotherapy group ,final irrigation with 2.5c cold saline solution for 5 mins will be performed following completion of biomechanical preparation whereas in control group same solution stored at room temperature will be used . treatment will be done in a single visit then participants will be asked to rate the intensity of postoperative pain using numerical rating scale at 6,12,24,48 hrs

Study Timeline

• Status Verified: 2018-10
• Study First Submitted: 2018-10-20
• Study First Submitted QC: 2018-10-20
• Last Update Submitted: 2018-10-22
• Study First Posted: 2018-10-23
• Last Update Posted: 2018-10-24
• Study Start: 2018-11
• Primary Completion: 2019-11
• Study Completion: 2019-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Age between 20-40 years old.
• Systemically healthy patient (ASA I or II).
• mandibular first molar teeth with:
• Preoperative sharp pain and Symptomatic apical periodontitis .absence or slight widening in the periodontal ligament (PDL). .Vital response of pulp tissue to cold pulp tester (ethyl chloride spray).
• Ability for isolation with rubberdam.
• Restorable teeth
• Ability to fill the root canals in single visit treatment.

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Exclusion Criteria

• Teeth without good apical constriction, such as wide or open apex
• Use of any type of analgesics or antibiotic medications within 3 days .Pregnant or nursing females.
• Patients having significant systemic disorder (ASA III or IV).
• Teeth that have :

Non vital pulp tissues. Association with swelling or fistulous tract Acute or chronic periapical abscess Greater than grade I mobility Pocket depth greater than 5 mm No possible restorability

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
normal saline	normal saline	room temperature saline is used as a final flush after chemicomechanical preparation
cryotherapy	cryotherapy	2.5c cold saline as a final flush after chemicomechanical debridement

Primary Outcome Measures

Name	Time	Method
postoperative pain assessed by NRS	up to 48 hrs postoperative pain	Primary outcome (post-operative pain) will be collected by the operator through (NRS) which is an 11 point scale consisting of numbers from 0 through 10 0: reading represents "no pain"; 1- 3: readings represent "mild pain" 4- 6: readings represent "moderate pain" 7- 10: readings represent "severe pain"

Secondary Outcome Measures

Name	Time	Method
amount of analgesics assessed by counting	up to 48 hrs postoperatively	number of analgesics tablets up to 48 hrs postoperatively